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  • STAT invites reader letters on primary care value, obesity as disease and broader health-care debates
    STAT’s First Opinion platform encourages readers to submit letters responding to its essays, fostering open, good‑faith discussion about health‑care topics. Recent letters, echoing comments from t…
    STAT · 1mo agoNeutral↗ source
  • Sonothera reports ultrasound method delivers high levels of dystrophin in monkeys, a potential new route for Duchenne therapy
    A California startup, Sonothera, is proposing an ultrasound‑based approach to deliver genes for Duchenne muscular dystrophy treatment. The company says its technology can introduce full-size dystr…
    STAT · 1mo agoPositive readoutNeutral↗ source
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  • Medicare proposal would boost doctor pay for smoking and alcohol counseling by 19%
    A proposed change to Medicare’s physician fee schedule would increase reimbursement for doctors who provide counseling on tobacco cessation and alcohol or substance misuse. The proposal adds a 19%…
    STAT · 1mo agoRegulatoryPositive↗ source
  • India’s life-sciences sector faces scaling hurdles despite rapid innovation growth, report says
    India’s life‑sciences sector has shown rapid growth, according to a new report by Boston Consulting Group and HealthKois. Patent filings have risen more than four‑fold since 2016, the pipeline of i…
    BioSpace · 1mo agoNeutral↗ source
  • U.S. drug shortages climb to 227 active cases in Q2 2026
    The United States reported a rise in active medication shortages during the second quarter of 2026, with the total reaching 227. The increase signals growing pressure on the pharmaceutical supply…
    STAT · 1mo agoNeutral↗ source
  • GSK drops chronic cough drug camlipixant after mixed Phase 3 results
    GSK announced it will stop investing in camlipixant for refractory chronic cough after the drug failed to meet key endpoints in a late-stage trial. The company had run two Phase 3 studies, CALM-1…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Insmed's inhaled PAH therapy shows durable efficacy in 12-month extension, bolstering $6B sales outlook
    Insmed reported that its inhalable prostanoid candidate, treprostinil palmitil inhalation powder (TPIP), maintained functional and biomarker benefits through a 12‑month open‑label extension in pati…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • FDA says former officials' journal articles do not represent agency policy after lawmaker criticism
    Acting FDA director Kyle Diamantas wrote to House Energy & Commerce ranking member Diana DeGette, stating that journal papers authored by former agency officials do not convey FDA policy or regulat…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • MDCalc introduces quality-rating system for over 800 clinical calculators used by doctors
    MDCalc, a health‑technology company, announced a new quality‑rating system that will evaluate the more than 800 clinical calculators doctors rely on for decisions such as kidney function, birth out…
    STAT · 1mo agoPositive↗ source
  • FDA proposal to drop adequate provision could effectively ban prescription drug ads
    FDA staff are proposing to eliminate the adequate provision requirement in direct-to-consumer prescription-drug advertisements. The adequate provision currently obliges advertisers to present a bal…
    raps · 1mo agoRegulatoryNegative↗ source
  • Pharma industry backs FDA NGS guidance but seeks clarification on off-target data and manufacturing changes
    The pharmaceutical sector has broadly endorsed the FDA's recent guidance on using next‑generation sequencing to evaluate the safety of human gene‑therapy products. Despite this support, companies…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA staff flag peptide conflict concerns and warn drug ad rule could curb advertising
    FDA staff have raised internal concerns about potential conflicts of interest among experts who will sit on an upcoming advisory panel reviewing peptide therapies. The staff memo warns that undiscl…
    raps · 1mo agoRegulatoryNegative↗ source
  • CDC links Taco Bell lettuce in five states to cyclospora outbreak
    Federal health officials have identified shredded iceberg lettuce from Mexico served at Taco Bell restaurants in Indiana, Kentucky, Michigan, Ohio and West Virginia as the source of a widespread cy…
    STAT · 1mo agoRegulatoryNegative↗ source
  • GSK discontinues its chronic cough therapy amid uncertain future
    GSK has announced that it is ending development of its chronic cough treatment. The decision marks the conclusion of the program that had been under investigation for several years. The article do…
    STAT · 1mo agoNegative↗ source
  • Sonothera touts ultrasound gene-delivery platform for Duchenne, but experts remain skeptical
    Sonothera, a California startup, says its ultrasound‑based technology can deliver therapeutic genes into cells, a method it believes could treat Duchenne muscular dystrophy and other genetic disord…
    STAT · 1mo agoNeutral↗ source
  • Opinion: MAHA pushes psychiatric deprescribing agenda, reshaping mental-health language
    Sunny Patel, an associate professor of psychiatry and pediatrics at Georgetown University, critiques the Mental Health Advocacy (MAHA) movement in a recent opinion piece. He notes her background wi…
    STAT · 1mo agoNegative↗ source
  • Ichnos Glenmark Innovation appoints Mariana Cota Stirner as chief medical officer
    Ichnos Glenmark Innovation announced the appointment of a new chief medical officer. Mariana Cota Stirner will assume the role, bringing experience from her recent position as fractional chief med…
    STAT · 1mo agoNeutral↗ source
  • Canadian wildfires drive NYC asthma ER visits up 31% as heat wave intensifies haze
    Recent Canadian wildfires have produced massive smoke plumes that have drifted into the United States, degrading air quality across many cities. In New York City, emergency department visits for a…
    STAT · 1mo agoNeutral↗ source
  • Trump administration moves to restore LGBTQ+ youth counseling on 988 line amid concerns over trans identity exclusion
    Specialized counseling services for LGBTQ+ youth are slated to return to the 988 Suicide & Crisis Lifeline by the end of the year, according to a recent confirmation from the Trump administration.…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Taylor Fresh Foods recalls all iceberg lettuce from central Mexico over possible Cyclospora contamination
    Taylor Fresh Foods, operating as Taylor Farms de Mexico in Guanajuato, is voluntarily removing all iceberg lettuce sourced from central Mexico from the U.S. market because of a potential Cyclospora…
    fda recalls · 1mo agoCRLNegative↗ source
  • Merck wins FDA nod for first oral PCSK9 inhibitor, Lipfendra, to treat high LDL cholesterol
    Merck announced that the U.S. Food and Drug Administration has approved its once-daily oral PCSK9 inhibitor, enlicitide, marketed as Lipfendra, for adults with elevated LDL cholesterol. The drug i…
    BioSpace · 1mo agoApprovalPositive↗ source
  • FDA approves Merck’s first oral PCSK9 inhibitor, marking a first for the drug class
    The U.S. Food and Drug Administration has granted approval to Merck for its oral PCSK9 inhibitor, the first drug of this type to receive such clearance. The approval represents a milestone because…
    STAT · 1mo agoApprovalPositive↗ source
  • Eli Lilly to buy psychedelics biotech AtaiBeckley for $2.8 billion
    Eli Lilly announced it will acquire AtaiBeckley, a biotech focused on psychedelic therapies for mental health, for an upfront cash payment of $2.8 billion. The purchase adds a new dimension to Lil…
    STAT · 1mo agoDealPositive↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…
    raps · 1mo agoApprovalPositive↗ source
  • Eli Lilly to acquire AtaiBeckley in up to $3.8 billion deal, entering psychedelics market
    Eli Lilly announced it will buy AtaiBeckley, offering $6.75 per share for the company’s common stock. The transaction includes an upfront commitment of about $2.8 billion and a contingent value rig…
    BioSpace · 1mo agoDealPositive↗ source